This study will collect blood and tissue samples from patients with human immunodeficiency virus (HIV) infection, Kaposi's sarcoma-associated herpes virus infection (KSHV) or with cancers associated with viral infections. The samples will be used for research relating to the patient's cancer or virus, to the immune system, or to methods of devising new therapies for these conditions.

Patients 18 years or older with HIV infection or malignancy, or high-risk exposure to HIV or KSHV may be eligible for this study.

Upon entering the study, patients will have 3 to 4 tablespoons of blood drawn for use in experimental research studies. Additional samples of the same amount may be requested periodically at later intervals.

Patients may be asked to have a biopsy (removal of a sample of tumor or normal tissue) as part of their medical care, or for another research study they are participating in. Part of the sample obtained will be used for research. If a biopsy is not required for other reasons, permission will be requested to perform a biopsy as part of this protocol. Samples may be obtained by withdrawing bone marrow through a small needle, removing fluid from the chest or abdomen through a needle or other instrument; withdrawing a tumor sample through a needle (called a needle aspiration), or removing a sample by making a small incision into or around the tumor. The method used will depend in part upon the location of the tumor.

Condition
HIV Infection Kaposi's Sarcoma

Further Study Details: 

Expected Total Enrollment:  9999

Patients with a prior diagnosis of HIV infection or malignancy, or a high-risk exposure to HIV or to the Kaposi's sarcoma-associated herpes virus (KSHV), will be evaluated in the Medical Oncology Clinic. Blood samples may be collected at the initial visit, and at follow-up visits. Tumor samples may be obtained by fine needle aspirate, by removal of pleural or peritoneal fluid, by skin punch biopsy, or by excisional biopsy, providing the tumor is accessible with minimal risk to the patients. Specific risks will be described in a separate consent to be obtained at the time of the biopsy. Tumor samples and blood samples will be processed and stored in the HIV and AIDS Malignancy Branch and/or the Department of Pathology, DCS, NCI, for use in the research efforts of the Branch.

Genders Eligible for Study:  Both

Criteria

INCLUSION CRITERIA:
Age 18 years or older.
ECOG performance status less than or equal to 3.
At least one of the following: Exposure risk to HIV, KSHV, or HPV; HIV seropositive; KSHV seropositive; EBV seropositive; HTLV-1 seropositive; Malignancy, Castleman's disease, or skin lesions with appearance of Kaposi's sarcoma; or Cervical or anal intraepithelial lesion.
Patients not requiring biopsy for a medical indication can be included on the study solely for the purpose of obtaining research samples, including blood, pleural fluid, peritoneal fluid, or biopsy samples providing the biopsy or aspiration procedure is of low risk.
EXCLUSION CRITERIA:
Inability to provide informed consent.

Maryland
      National Cancer Institute (NCI), 9000 Rockville Pike,  Bethesda,  Maryland,  20892,  United States; Recruiting

Study ID Numbers:  010038; 01-C-0038
Record last reviewed:  November 1, 2004
Last Updated:  November 23, 2004
Record first received:  November 22, 2000
ClinicalTrials.gov Identifier:  NCT00006518
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08